FDA Urged to Reduce Doses of Tylenol and Excedrin

The maximum daily doses of Tylenol, Excedrin, and dozens of other painkillers and fever-reducing drugs should be lowered in an effort to prevent potentially deadly overdoses of acetaminophen, a Food and Drug Administration panel said.

Each year, about 56,000 people are treated in emergency rooms across the United States for overdoses of acetaminophen. The drug, one of the most commonly used medications found in over-the-counter and prescription products for over 50 years, remains a leading cause of liver damage and liver failure.

Millions of people take acetaminophen products for mild aches, pains, and fevers instead of aspirin or ibuprofen, which can cause ulcers.

The FDA sought advice from a panel of physicians and medical experts about what steps should be taken by the agency to avoid accidental acetaminophen overdoses. The advisory panel vote comes on day two of a series of FDA meetings to address how to curb accidental overdoses of acetaminophen. Further actions may be recommended later at the meeting.

Panel Votes to Lower Doses

The panel voted 21-16 to recommend that the FDA lower the maximum daily dosage of drugs such as Extra Strength Tylenol. The drugs currently carry a maximum daily dose of four grams, which typically amounts to eight pills a day.

However, that much acetaminophen is close to levels of the drug that can severe liver failure, health officials caution. The advisory panel was not asked to recommend to what amount the daily maximum dose should be lowered.

The advisory panel also voted 24-13 to limit the maximum single dose of Extra Strength Tylenol to 650 milligrams. The current single dose of the drug is 1,000 milligrams, or two tablets. A majority of panelists also recommended that the 1,000-mg dose of Extra Strength Tylenol should be available only with a prescription.

Combination Drugs Also Under Consideration

Later today, the same panel is expected to vote on whether some acetaminophen products should be pulled from the market because of concerns about accidental overdoses. Combination drugs such as NyQuil and Theraflu, which use acetaminophen and other medications to treat cough and runny nose, could be ordered off the market, although such a sweeping move is not expected.

While the FDA is not obligated to follow the recommendations of its advisory panels, the agency most often does. An FDA decision on changes to the daily maximum doses of acetaminophen-based products and other new restrictions could come in the next few weeks or months.

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